BACKGROUNDHead-to-head comparisons of second and third generations of THVs are mostly limited to two-arm studies, and to mid-term follow-up so far. Aim of the study was to simultaneously compare clinical outcomes of transcatheter aortic valve replacement (TAVR) with four different transcatheter heart valves (THVs) at 5 years. METHODSPatients undergoing transfemoral TAVR with four second-generation THV platforms and enrolled in the multicenter, prospective OBSERVANT II study from December 2016 to September 2018, were compared according to the THV received. Outcomes were adjudicated through a linkage with administrative databases and adjusted using inverse propensity of treatment weighting (IPTW) based on propensity score.The primary endpoints were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 5 years. Cumulative rates were reported consecutively for Evolut R/ PRO, SAPIEN 3, ACURATE neo and Portico groups. RESULTSA total of 2,493 patients were considered. The median age was 83 years and the median EuroSCORE 2 was 4.9%. After IPTW adjustment, the rates of all-cause death (53.6% vs. 46.7% vs. 50.5% vs. 46.3%, p=0.06) and MACCE (57.2% vs. 51.2% vs. 54.4% vs. 50.6%, p=0.08) did not differ among groups at 5 years. The rate of re-hospitalization for heart failure (HF) (33.9% vs. 27.0% vs. 31.6% vs. 33.7%, p=0.02) was significantly lower for SAPIEN 3 THV at 5 years. CONCLUSIONSData from real-world practice showed sustained and comparable effectiveness of TAVR considering all the available THVs up to 5 years, but SAPIEN 3 showed a lower rate of rehospitalization for HF.
Read full abstract